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Neurocognitive Functioning in Patients With Newly Diagnosed Upper Aerodigestive Tract Cancer Receiving Treatment at Henry-Joyce Cancer Clinic

5 de abril de 2017 actualizado por: Vanderbilt University Medical Center

Neurocognitive Functioning in Adults With Upper Aerodigestive System Cancers

RATIONALE: Gathering information about how often problems with neurocognitive functioning occur in patients with newly diagnosed upper aerodigestive tract cancers may help doctors learn more about the disease.

PURPOSE: This clinical trial is studying neurocognitive functioning in patients with newly diagnosed upper aerodigestive tract cancers receiving treatment at Henry-Joyce Cancer Clinic.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

OBJECTIVES:

Primary

  • To establish an estimate of the prevalence of baseline neurocognitive impairment prior to initiation of outpatient cancer treatment.
  • To establish an estimate of the incidence of neurocognitive impairment during outpatient cancer treatment.
  • To describe how neurocognitive functioning changes over time during cancer treatment.

Secondary

  • To identify sociodemographic and clinical factors associated with neurocognitive impairment.
  • To examine health-related outcomes associated with neurocognitive impairment.

OUTLINE: Patients undergo interview to complete measures of domain-specific neurocognitive functioning, global neurocognitive functioning, subjective neurocognitive functioning, delirium, physical functioning, symptom prevalence and distress, mood states, and medications at baseline before initiation of cancer treatment, at scheduled treatment visits, and at the follow-up visit 3 months after completion of cancer treatment.

Measures of comorbidity, alcohol use, sensory functioning (vision and hearing), and sociodemographic are completed at baseline only. Cancer-related information (diagnosis, staging, and sites of metastasis, if applicable), treatment-related information (planned treatment regimen - chemotherapy and/or radiation therapy), and current medications are obtained at baseline by medical record review.

Health service use and complications are assessed at each scheduled treatment visit and at the 3-month post-treatment follow-up visit. Measures of domain-specific neurocognitive functioning, coping, and quality of life are completed at baseline and at the 3-month follow-up visit.

Tipo de estudio

De observación

Inscripción (Actual)

86

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37208
        • MBCCOP - Meharry Medical College - Nashville
      • Nashville, Tennessee, Estados Unidos, 37232-6838
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, Estados Unidos, 37064
        • Vanderbilt-Ingram Cancer Center - Cool Springs
      • Nashville, Tennessee, Estados Unidos, 37064
        • Vanderbilt-Ingram Cancer Center at Franklin

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

21 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Patients with newly diagnosed upper aerodigestive system cancers (head and neck, lung, and esophagus)

Descripción

DISEASE CHARACTERISTICS:

  • Newly diagnosed solid tumors of the upper aerodigestive system, including cancers of the head and neck, esophagus, or lung
  • Receiving treatment at the Henry-Joyce Cancer Clinic at the Vanderbilt-Ingram Cancer Center
  • No known brain metastasis

PATIENT CHARACTERISTICS:

  • Able to hear, speak, and understand English
  • No prior diagnosis of other cancer except basal cell carcinoma

PRIOR CONCURRENT THERAPY:

  • No treatment plans including prophylactic cranial irradiation

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Treatment
Patients undergoing treatment for head and neck, lung, and esophagus cancers
Otro: Assessment of therapy complications
Assessment of neurocognitive function, functional status, symptom prevalence and distress, and mood alterations
Otro: Neurocognitive assessment
Assessment of neurocognitive domains: attention/concentration, executive function, verbal learning, verbal memory, verbal fluency
Otro: Quality-of-life assessment
Assessment of quality of life using Cantrill's Ladder at baseline and 3 months post-treatment

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Domain-Specific Neurocognitive Functioning measuring attention, executive functioning, mental processing speed, verbal memory, language, and visuospatial construction at baseline and 3 months after completion of treatment
Periodo de tiempo: Baseline and 3 months post-treatment
Baseline and 3 months post-treatment
Global neurocognitive functioning as measured by the Mini-Mental State Examination (MMSE)
Periodo de tiempo: Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Self-reported neurocognitive symptoms as measured by the Alertness Behavior Subscale of the Sickness Impact Profile
Periodo de tiempo: Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Delirium and delirium symptoms by the NEECHAM Confusion Scale and Confusion Assessment Method (CAM)
Periodo de tiempo: Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Baseline, at each scheduled treatment visit, and at 3 months post-treatment

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Alcohol, tobacco, and drug use as measured by the Alcohol Use Disorders Identification Test (AUDIT)
Periodo de tiempo: Baseline
Baseline
Premorbid intellectual functioning as measured by the North American Adult Reading Test (NAART)
Periodo de tiempo: Baseline
Baseline
Functional status measured by the Duke Older Americans Resources and Services (OARS) Activities of Daily Living Scale
Periodo de tiempo: Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Symptom prevalence and distress measured using the short form of the Memorial Symptom Assessment Scale (MSASSF)
Periodo de tiempo: Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Mood State measured by the Profile of Mood States (POMS-SF)
Periodo de tiempo: Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Overall quality of life measured using Cantril's Ladder
Periodo de tiempo: Baseline and 3 months post-treatment
Baseline and 3 months post-treatment
Coping measured by the Mini-Mental Adjustment to Cancer Scale (Mini-MAC)
Periodo de tiempo: Baseline and 3 months post-treatment
Baseline and 3 months post-treatment
Hospitalizations, emergency department visits, and unscheduled clinic visits
Periodo de tiempo: At each scheduled treatment visit and 3 months post-treatment
At each scheduled treatment visit and 3 months post-treatment
Falls, injuries, and other complications
Periodo de tiempo: At each scheduled treatment visit and 3 months post-treatment
At each scheduled treatment visit and 3 months post-treatment

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Vanderbilt University Medical Center

Colaboradores

National Cancer Institute (NCI)

Investigadores

  • Silla de estudio: Stewart M. Bond, PhD, RN, Vanderbilt-Ingram Cancer Center

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de octubre de 2007

Finalización primaria (Actual)

1 de mayo de 2010

Finalización del estudio (Actual)

1 de junio de 2013

Fechas de registro del estudio

Enviado por primera vez

20 de septiembre de 2007

Primero enviado que cumplió con los criterios de control de calidad

20 de septiembre de 2007

Publicado por primera vez (Estimar)

24 de septiembre de 2007

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

7 de abril de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

5 de abril de 2017

Última verificación

1 de abril de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CDR0000565963
  • P30CA068485 (Subvención/contrato del NIH de EE. UU.)
  • VU-VICC-SUPP-0751

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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